ibodutant for relief of irritable bowel syndrome with diarrhoea (ibs-d)

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: irritable bowel syndrome with diarrhoea (ibs-d) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. this trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist ibodutant in improving ibs-d symptoms.

the study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in ibs-d patients. efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. the clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient. patients report their ibs-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.

Eligibility criteria:
inclusion criteria: at start of the run-in period: * male or female patients aged 18 - 70 years with a clinical diagnosis of ibs-d according to the rome iii criteria: * recurrent abdominal pain/discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: 1. improvement with defecation; 2. onset associated with a change in the frequency of stool; 3. onset associated with a change in form (appearance) of stool. * symptom-onset at least 6 months prior to diagnosis. * loose/watery stools at least 25% of the time in the last 3 months and hard/lumpy stools less than 25% of the time in the last 3 months. * more than 3 bowel movements per day at least 25% of the time in the last 3 months. * for patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy. * mentally competent, able to give written informed consent. * for women of childbearing potential: use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment. * normal physical examination or without clinically relevant abnormalities. at randomisation: -confirmation of ibs-d severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period. exclusion criteria: * organic abnormalities of the gastrointestinal tract, including history of colonic or major abdominal surgery. * history of gluten enteropathy. * lactose intolerance as assessed by response to diet. * history of positive tests for ova or parasites, or occult blood in the stool. * previous diagnosis of diabetes mellitus (either type 1 or 2). * unstable medical condition. * major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease. * relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. * use of concurrent medication with drugs known to interfere with gastro-intestinal motility or sensitivity. * pregnancy or breastfeeding.

Keywords: irritable bowel syndrome colon, irritable bowel disease